Evaluation of a Non-invasive Brain Compliance Measurement Device

Completed

• Conditions: Diabetes; Diabetic Ketoacidosis
• Interventions: Other: this is not an intervention study; Device: MRI

• Registration Number: NCT01753921
• Lead Sponsor: Stanford University

Brief Summary

This is a research study to understand how diabetic ketoacidosis may affect the brain and learning and to see if these changes are transient or permanent. The investigators hope to learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave System™ (NNS), learning, talking, behavior, or development. The investigators will compare those results from those with diabetes mellitus to those age and gendered matched healthy controls. Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17 years old.

Detailed Description

At enrollment, 1 week, 1 month, 3 month, 12 month Computerized neurocognitive testing Wear NNS

MRI of the brain at 3 month and 12 months

Formal neurocognitive testing at 3 months and 12 months

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

To be eligible for the study, all subjects must meet the following criteria:

1. Healthy control OR
2. Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines
3. Age 10 years to less than 17 years
4. Parent/guardian understand the study protocol and agrees to comply with it.
5. Primary care giver (i.e parent/guardian) comprehends written English. This is due to the fact that questionnaires and neurocognitive testing tools used as outcome measures do not have validated versions in Spanish or other language. Subject comprehends and speaks English.

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Exclusion Criteria

Subjects who meet any of the following criteria are not eligible for the study:

1. History of head trauma with any loss of consciousness
2. History of premature birth (less than 30 weeks of gestation)
3. History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age
4. History of neurologic disease independent of diabetes (seizure disorder)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DKA Group	this is not an intervention study	Subjects who presented in diabetic ketoacidosis.
Healthy control	MRI	Control subjects without diabetes.
DKA Group	MRI	Subjects who presented in diabetic ketoacidosis.
Healthy control	this is not an intervention study	Control subjects without diabetes.

Primary Outcome Measures

Name	Time	Method
Unique signal measured in Hertz	3 months	We will be using the brain compliance measurement device to see if there is a unique signal for those with DKA and if so, follow the duration of this signal.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States